BioCentury
ARTICLE | Product Development

Oct. 14 Quick Takes: FDA approves first Ebola therapy; plus Vertex tumbles after hours on AAT discontinuation

Updates on Russia’s latest COVID-19 vaccine approval and more

October 15, 2020 2:08 AM UTC

Regenerons Ebola mAb cocktail approved
FDA approved Inmazeb atoltivimab/maftivimab/odesivimab-ebgn from  Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat Zaire ebolavirus infection. The mAb cocktail had raised the chance of survival vs. ZMapp, a mAb combination used as a control, in the PALM study. Under a July deal, Regeneron will deliver to the U.S. Biomedical Advanced Research and Development Authority (BARDA) an undisclosed number of Inmazeb doses over six years in exchange for about $10 million next year and $67 million per year in 2022-26. It is FDA’s first approval of an Ebola therapy.

Vertex discontinues VX-814 for AAT deficiency
Shares of Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) fell 14% after hours after the company said it has discontinued development of VX-814 based on the candidate’s safety and pharmacokinetic profile in a Phase II trial to treat alpha-1 antitrypsin (AAT) deficiency. The company will continue Phase II testing of VX-864, another small molecule corrector for AAT deficiency. Data are expected in 1H21 for VX-864, which Vertex said is structurally distinct from VX-814. ...